Genetically Engineered Salmon Closer to U.S. Approval

WASHINGTON, DC, December 26, 2012 (ENS) – Genetically engineered salmon are likely to appear on American dinner plates for the first time in the near future, following the U.S. Food and Drug Administration’s finding that they pose “no significant impact” to the environment.

Posted in the Federal Register today, the documents containing the FDA’s findings are available for public comment until February 25, 2013.

The two documents – a draft environmental assessment and a preliminary “finding of no significant impact” – relate to AquAdvantage® Salmon, the trademarked genetically engineered salmon product proposed for approval by AquaBounty Technologies of Massachusetts.

AquAdvantage® Salmon consists of Atlantic salmon eggs that contain a growth hormone gene from Chinook salmon, which provides the fish with the potential to reach market size in half the time of conventional Atlantic salmon.

Fish grown from AquAdvantage® Salmon eggs are all female and sterile. In addition, the FDA requires that, if approval of AquaBounty’s New Animal Drug Application is granted, the fish can only be grown in physically contained systems at approved facilities.

The genetically engineered salmon would not be farmed in the net pens that are standard on today’s fish farms.

Instead, fertilized AquAdvantage® Salmon eggs would be created in inland tanks on Canada’s Prince Edward Island. The eggs would be transported to an inland facility in Panama to grow to maturity in tanks.

AquaBounty Chief Executive Officer Ron Stotish said Monday, “We are delighted that the Environmental Assessment is to be published for comment, which brings us a major step closer to approval. The revival of the science based review process is encouraging and we look forward to a successful conclusion based on the merit of the product.”

Stotish says the FDA has not provided the company with an indication of the process or associated timing that will occur after the end of the public comment period.

The FDA made its preliminary finding of “no significant impact” despite a petition from conservation groups requesting that it complete a comprehensive environmental impact statement on the risks transgenic fish could present to the natural marine environment.

The nonprofit public interest law firm Earthjustice filed that petition in May 2011 on behalf of Ocean Conservancy, Friends of the Earth, Center for Food Safety, Food & Water Watch, the Center for International Environmental Law, and Greenpeace.

In its draft environmental assessment, the FDA accepts AquaBounty’s representation that no fish will escape, survive, or reproduce in the wild – even though the conservationists warn that type of security cannot be guaranteed.

Desai of Earthjustice said, “This genetically engineered fish puts the entire U.S. salmon industry at risk, and most importantly it could threaten the very survival of our native salmon populations.”

In their petition, the environmental groups ask for new regulations to govern the “burgeoning GE [genetically engineered] food animal industry” because the existing Federal Food, Drug, and Cosmetic Act, FFDCA, does not cover the situations created by these new technologies.

“The production and distribution of GE food animals like ABT’s AquAdvantage Salmon inherently pose unique environmental risks – including those threatening disruption and potential destruction of entire natural ecosystems – that are simply not contemplated by the FFDCA or its regulations,” the petition states.

AquaBounty replies in a November 2010 letter addressed to FDA Commissioner Dr. Margaret Hamburg posted on its website, “…in addition to being triploid (infertile), the fish are all female and will be raised in physically contained facilities which will be inspected and approved in advance by FDA. This redundant biological containment and the rigorous physical containment the facilities provide assures a much higher degree of certainty of no interaction with any wild population than does an other current production method, and in fact, renders comparisons with other current production methods wholly inappropriate.”

Nevertheless, the environmental groups warn, the process “occurs almost entirely behind closed doors, making it nearly impossible for the public to participate meaningfully in an agency decision that could lead to devastating and irreversible ecological harm.”

Although the FDA has hosted a public hearing on AquaBounty Technologies’ application and has stated that it will seek public comment on its National Environmental Policy Act document related to this application before publishing a final determination, the petitioning groups point out that these opportunities for public comment “are not presently required by law and therefore may not be afforded each time the Agency is considering approval of a GE food animal application.”

The public comment period now open for the environmental assessment and finding of “no significant impact” on AquaBounty’s AquAdvantage® Salmon relates only to the environmental impact of the transgenic salmon, not its safety as a food.

The food analysis has already been completed. In 2010, the FDA’s Veterinary Medicine Advisory Committee concluded that the engineered salmon “is as safe as food from conventional salmon, and there is a reasonable certainty of no harm from consumption.”

That panel concluded AquAdvantage® Salmon is indistinguishable from other Atlantic salmon, is safe to eat and does not pose a threat to the environment under its conditions of use.

At that time, conservation scientists called for a better procedure for determining the risks of genetically engineered food animals.

Margaret Mellon, a senior scientist with the Union of Concerned Scientists and director of the organization’s Food and Environment Program, said, “The approval process for this genetically engineered salmon will set an important precedent that will be difficult to reverse. If we do not implement a comprehensive and adequate procedure to oversee genetically engineered foods now, we could put human health and the environment at risk.”

Mellon, a lawyer with a doctorate in molecular biology, said FFDCA drug laws have two major deficiencies.

First, they do not require the FDA to convene scientific advisory committees as part of the approval process for genetically engineered animals.

Second, they do not have any provisions requiring environmental protection. A number of experts have concluded that AquaBounty’s salmon could threaten aquatic environments.

She also questioned the Veterinary Medicine Advisory Committee’s ability to handle this sensitive issue. It is the only committee the FDA will consult on the matter.

“Yes, this committee is sometimes asked to consider scientific, political and environmental risks as part of the approval process under the drug laws – as we are seeing with genetically engineered fish,” Mellon explained. “But it is largely made up of veterinarians who do not have the necessary expertise to evaluate the risks genetically engineered fish may pose to consumers or the environment.”